Regulatory Officer at Geneith Pharmaceuticals Limited

Geneith Pharmaceutical Limited was incorporated under the Company and Allied Matters Act (CAMA) 1990 on the Nineteenth day of January in the year 2000 as a private limited liability company limited to aid the attainment of excellent health standard by employing the best available technological resources to deliver innovative, high quality products to the satisfaction of the end user.

We are recruiting to fill the position of:

Job Title: Regulatory Officer

Location: Lagos

Job Description

• Act as a liaison with regulatory agencies to ensure the appropriate licensing, marketing, and legal compliance of pharmaceutical and medical products to control the safety and efficacy of products.
• Coordinate, prepare and review all appropriate documents, for example, CTD dossier and submit them to regulatory authorities within a specified time frame.
• To be involved in all stages of drug development and after drug approval and marketing.
• Keep track of the ever-changing legislation in all the regions where the company wishes to distribute its products.
• Involved in the Pharmacovigilance/Post Marketing surveillance of drugs.

Key Duties And Responsibilities

• Coordinate, prepare, and review CTD dossiers.
• Product registration with NAFDAC, monitoring and setting timelines for license variations and renewal approvals, import permits, clearing permits (for Narcotics), and facility inspection requests.
• Liaising with and making presentations to regulatory authorities.
• Processing product, pack size extension, and other applications as needed.
• Prompt communication of any compliance directive to the office for corrections.

Education & Work Experience

• Minimum of Bachelor's Degree in (Pharmacy, Microbiology) or its equivalent.
• Should be conversant with the regulatory requirements for CTD Dossier submission and possess vetting ability.
• Minimum of 2-3 years of working experience as a Regulatory Officer involved in NAFDAC procedures of product registration.
• Minimum of 1-2 years’ experience in NAFDAC-regulated industries involved in importation.

Application Closing Date
6th February, 2023.

Method of Application
Interested and qualified candidates should send their CV to: [email protected] using the Job Title as the subject of the email.